{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T15:54:46Z","timestamp":1786982086964,"version":"build-2736575974"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"7","license":[{"start":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T00:00:00Z","timestamp":1616025600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T00:00:00Z","timestamp":1616025600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"This investigator initiated research is supported by GRAND (Global Research Award for Nicotine Dependence) an independently reviewed competitive grants program funded by Pfizer Inc (US)."},{"DOI":"10.13039\/501100004505","name":"Universit\u00e0 degli Studi di Catania","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100004505","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Intern Emerg Med"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Reducing exposure to cigarette smoke is an imperative for public health and for diabetic patients. Patients with diabetes who continue to smoke face challenges at quitting and the delivery of effective smoking cessation interventions is a major unmet need. The high-affinity \u03b14\u03b22 nicotinic acetylcholine receptor partial agonist varenicline in combination with counseling is effective for smoking cessation, but evidence in patients with diabetes is limited. A clinical trial of varenicline targeted specifically at smokers with T2DM is warranted. This randomized, double blind, placebo-controlled trial will be the first study to test efficacy and safety of varenicline in smokers with type 2 diabetes mellitus (T2DM) over the course of 52\u00a0weeks. We hypothesize that varenicline treatment (1\u00a0mg BID, administered for 12\u00a0weeks) would increase quit rates, maintain smoking abstinence up to 1\u00a0year after treatment, and be well-tolerated in T2DM smokers intending to quit. Efficacy end points will include carbon monoxide\u2013confirmed continuous abstinence rate (CAR) and 7-day point prevalence of abstinence. The results of this RCT will help inform medical\/health authorities and physicians worldwide whether an optimally varenicline-treated cohort of T2DM patients who smoke will experience significant success rates, without significant side effects.<\/jats:p>\n                  <jats:p>\n                    Trial registration NCT01387425 (\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01387425\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01387425<\/jats:ext-link>\n                    ).\n                  <\/jats:p>","DOI":"10.1007\/s11739-021-02684-1","type":"journal-article","created":{"date-parts":[[2021,3,18]],"date-time":"2021-03-18T03:02:43Z","timestamp":1616036563000},"page":"1823-1839","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A double blind randomized controlled trial investigating efficacy and safety of varenicline for smoking cessation in patients with type 2 diabetes: study protocol"],"prefix":"10.1007","volume":"16","author":[{"given":"C.","family":"Russo","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Caponnetto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"F.","family":"Cibella","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Maglia","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Alamo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"D.","family":"Campagna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"L.","family":"Frittitta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M.","family":"Di Mauro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Leotta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Mondati","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Krysi\u0144ski","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Franek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8450-5721","authenticated-orcid":false,"given":"R.","family":"Polosa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,3,18]]},"reference":[{"key":"2684_CR1","doi-asserted-by":"crossref","unstructured":"Fowler MJ (2011) Microvascular and macrovascular complications of diabetes. Clin Diabetes 29(3): 116\u201322. http:\/\/clinical.diabetesjournals.org\/content\/diaclin\/29\/3\/116.full.pdf","DOI":"10.2337\/diaclin.29.3.116"},{"issue":"17","key":"2684_CR2","doi-asserted-by":"publisher","first-page":"1887","DOI":"10.2174\/092986707781058832","volume":"14","author":"RR Cacciola","year":"2007","unstructured":"Cacciola RR, Guarino F, Polosa R (2007) Relevance of endothelial-haemostatic dysfunction in cigarette smoking. Curr Med Chem 14(17):1887\u20131892","journal-title":"Curr Med Chem"},{"key":"2684_CR3","unstructured":"Guarino F, Cantarella G, Caruso M, Russo C, Mancuso S, Arcidiacono G, Cacciola RR, Bernardini R, Polosa R (2011) Endothelial activation and injury by cigarette smoke exposure. J Biol Regul Homeost Agents. 25(2):259\u201368. PMID: 21880215."},{"key":"2684_CR4","doi-asserted-by":"publisher","first-page":"10","DOI":"10.1186\/s12958-019-0557-9","volume":"18","author":"D Mollaioli","year":"2020","unstructured":"Mollaioli D, Ciocca G, Limoncin E et al (2020) Lifestyles and sexuality in men and women: the gender perspective in sexual medicine. Reprod Biol Endocrinol 18:10. https:\/\/doi.org\/10.1186\/s12958-019-0557-9","journal-title":"Reprod Biol Endocrinol"},{"key":"2684_CR5","doi-asserted-by":"publisher","first-page":"2360","DOI":"10.2337\/dc10-0846","volume":"33","author":"KM Nelson","year":"2010","unstructured":"Nelson KM, Boyko EJ, Koepsell T (2010) All-cause mortality risk among a national sample of individuals with diabetes. Diabetes Care 33:2360\u20132364","journal-title":"Diabetes Care"},{"issue":"7","key":"2684_CR6","doi-asserted-by":"publisher","first-page":"1736","DOI":"10.2337\/dc07-0305","volume":"30","author":"LN McEwen","year":"2007","unstructured":"McEwen LN, Kim C, Karter AJ, Haan MN, Ghosh D, Lantz PM, Mangione CM, Thompson TJ, Herman WH (2007) Risk factors for mortality among patients with diabetes: the Translating Research Into Action for Diabetes (TRIAD) Study. Diabetes Care 30(7):1736\u20131741","journal-title":"Diabetes Care"},{"key":"2684_CR7","doi-asserted-by":"crossref","unstructured":"Wei M, Gaskill SP, Haffner SM, Stern MP (1998) Effects of diabetes and level of glycemia on all-cause and cardiovascular mortality. The San Antonio Heart Study. Diabetes Care 21(7):1167\u201372.","DOI":"10.2337\/diacare.21.7.1167"},{"issue":"11","key":"2684_CR8","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1186\/s13098-019-0482-2","volume":"24","author":"D Campagna","year":"2019","unstructured":"Campagna D, Alamo A, Di Pino A, Russo C, Calogero AE, Purrello F, Polosa R (2019) Smoking and diabetes: dangerous liaisons and confusing relationships. Diabetol Metab Syndr 24(11):85. https:\/\/doi.org\/10.1186\/s13098-019-0482-2","journal-title":"Diabetol Metab Syndr"},{"issue":"2","key":"2684_CR9","doi-asserted-by":"publisher","first-page":"342","DOI":"10.1016\/j.ijcard.2011.12.100","volume":"167","author":"R Qin","year":"2013","unstructured":"Qin R, Chen T, Lou Q, Yu D (2013) Excess risk of mortality and cardiovascular events associated with smoking among patients with diabetes: meta-analysis of observational prospective studies. Int J Cardiol 167(2):342\u2013350. https:\/\/doi.org\/10.1016\/j.ijcard.2011.12.100","journal-title":"Int J Cardiol"},{"issue":"19","key":"2684_CR10","doi-asserted-by":"publisher","first-page":"1795","DOI":"10.1161\/CIRCULATIONAHA.115.017926","volume":"132","author":"A Pan","year":"2015","unstructured":"Pan A, Wang Y, Talaei M, Hu FB (2015) Relation of smoking with total mortality and cardiovascular events among patients with diabetes mellitus: a meta-analysis and systematic review. Circulation 132(19):1795\u20131804","journal-title":"Circulation"},{"key":"2684_CR11","doi-asserted-by":"publisher","first-page":"1391","DOI":"10.1007\/s40618-020-01257-x","volume":"43","author":"G Corona","year":"2020","unstructured":"Corona G, Sansone A, Pallotti F et al (2020) People smoke for nicotine, but lose sexual and reproductive health for tar: a narrative review on the effect of cigarette smoking on male sexuality and reproduction. J Endocrinol Invest 43:1391\u20131408. https:\/\/doi.org\/10.1007\/s40618-020-01257-x","journal-title":"J Endocrinol Invest"},{"key":"2684_CR12","doi-asserted-by":"publisher","unstructured":"Standards of medical care in diabetes\u20132015: summary of revisions. Diabetes Care 2015;38 Suppl:S4. https:\/\/doi.org\/10.2337\/dc15-S003.","DOI":"10.2337\/dc15-S003"},{"issue":"3","key":"2684_CR13","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1016\/j.coph.2012.02.005","volume":"12","author":"P Caponnetto","year":"2012","unstructured":"Caponnetto P, Russo C, Polosa R (2012) Smoking cessation: present status and future perspectives. Curr Opin Pharmacol 12(3):229\u2013237","journal-title":"Curr Opin Pharmacol"},{"issue":"5","key":"2684_CR14","doi-asserted-by":"publisher","first-page":"281","DOI":"10.1016\/j.tips.2010.12.008","volume":"32","author":"R Polosa","year":"2011","unstructured":"Polosa R, Benowitz NL (2011) Treatment of nicotine addiction: present therapeutic options and pipeline developments. Trends Pharmacol Sci 32(5):281\u2013289","journal-title":"Trends Pharmacol Sci"},{"issue":"3","key":"2684_CR15","doi-asserted-by":"publisher","first-page":"e004107","DOI":"10.1136\/bmjopen-2013-004107","volume":"4","author":"A Nagrebetsky","year":"2014","unstructured":"Nagrebetsky A, Brettell R, Roberts N, Farmer A (2014) Smoking cessation in adults with diabetes: a systematic review and meta-analysis of data from randomised controlled trials. BMJ Open 4(3):e004107. https:\/\/doi.org\/10.1136\/bmjopen-2013-004107","journal-title":"BMJ Open"},{"key":"2684_CR16","doi-asserted-by":"publisher","first-page":"541","DOI":"10.1016\/j.amjmed.2012.11.029","volume":"126","author":"C Clair","year":"2013","unstructured":"Clair C, Meigs JB, Rigotti NA (2013) Smoking behavior among US adults with diabetes or impaired fasting glucose. Am J Med 126:541","journal-title":"Am J Med"},{"key":"2684_CR17","doi-asserted-by":"publisher","first-page":"E160","DOI":"10.5888\/pcd10.120259","volume":"10","author":"AZ Fan","year":"2013","unstructured":"Fan AZ, Rock V, Zhang X, Li Y, Elam-Evans L, Balluz L (2013) Trends in cigarette smoking rates and quit attempts among adults with and without diagnosed diabetes, United States, 2001\u20132010. Prev Chronic Dis 10:E160. https:\/\/doi.org\/10.5888\/pcd10.120259","journal-title":"Prev Chronic Dis"},{"issue":"10","key":"2684_CR18","doi-asserted-by":"publisher","first-page":"3474","DOI":"10.1021\/jm050069n","volume":"48","author":"JW Coe","year":"2005","unstructured":"Coe JW, Brooks PR, Vetelino MG, Wirtz MC, Arnold EP, Huang J, Sands SB, Davis TI, Lebel LA, Fox CB, Shrikhande A, Heym JH, Schaeffer E, Rollema H, Lu Y, Mansbach RS, Chambers LK, Rovetti CC, Schulz DW, Tingley FD 3rd, O\u2019Neill BT (2005) Varenicline: an alpha4beta2 nicotinic receptor partial agonist for smoking cessation. J Med Chem 48(10):3474\u20133477","journal-title":"J Med Chem"},{"key":"2684_CR19","doi-asserted-by":"crossref","unstructured":"Cahill K, Stevens S, Perera R, Lancaster T (2013) Pharmacological interven- tions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev 31:CD009329.","DOI":"10.1002\/14651858.CD009329.pub2"},{"key":"2684_CR20","doi-asserted-by":"publisher","first-page":"588","DOI":"10.3109\/07853890.2012.705016","volume":"44","author":"EJ Mills","year":"2012","unstructured":"Mills EJ, Wu P, Lockhart I, Thorlund K, Puhan M, Ebbert JO (2012) Comparisons of high-dose and combination nicotine replacement therapy, varenicline, and bupropion for smoking cessation: a systematic review and multiple treatment meta-analysis. Ann Med 44:588\u2013597","journal-title":"Ann Med"},{"key":"2684_CR21","doi-asserted-by":"publisher","first-page":"221","DOI":"10.1161\/CIRCULATIONAHA.109.869008","volume":"121","author":"NA Rigotti","year":"2010","unstructured":"Rigotti NA, Pipe AL, Benowitz NL et al (2010) Efficacy and safety of varenicline for smoking cessation in patients with cardiovascular disease: a randomized trial. Circulation 121:221\u2013229","journal-title":"Circulation"},{"key":"2684_CR22","doi-asserted-by":"publisher","first-page":"591","DOI":"10.1378\/chest.10-0865","volume":"139","author":"DP Tashkin","year":"2011","unstructured":"Tashkin DP, Rennard S, Hays JT et al (2011) Effects of varenicline on smoking cessation in patients with mild to moderate COPD: a randomized controlled trial. Chest 139:591\u2013599","journal-title":"Chest"},{"key":"2684_CR23","doi-asserted-by":"publisher","first-page":"390","DOI":"10.7326\/0003-4819-159-6-201309170-00005","volume":"159","author":"RM Anthenelli","year":"2013","unstructured":"Anthenelli RM, Morris C, Ramey TS et al (2013) Effects of varenicline on smoking cessation in adults with stably treated current or past major depression: a randomized trial. Ann Int Med 159:390\u2013400","journal-title":"Ann Int Med"},{"key":"2684_CR24","doi-asserted-by":"publisher","unstructured":"American Diabetes Association (2010) Diagnosis and classification of diabetes mellitus. Diabetes Care 33 Suppl 1(Suppl 1): S62\u2013S69. https:\/\/doi.org\/10.2337\/dc10-S062.","DOI":"10.2337\/dc10-S062"},{"key":"2684_CR25","doi-asserted-by":"crossref","unstructured":"Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, et al (2006) Varenicline phase 3 study group. Varenicline, an alpha4beta2 nicotinic acetyl\u2013choline receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA 296:47\u201355 [PMID: 16820546]","DOI":"10.1001\/jama.296.1.47"},{"key":"2684_CR26","doi-asserted-by":"crossref","unstructured":"Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, et al; Varenicline phase 3 study group (2006) Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA 296:56\u201363 [PMID: 16820547]","DOI":"10.1001\/jama.296.1.56"},{"key":"2684_CR27","doi-asserted-by":"publisher","first-page":"1040","DOI":"10.1016\/j.clinthera.2007.06.012","volume":"29","author":"M Nakamura","year":"2007","unstructured":"Nakamura M, Oshima A, Fujimoto Y, Maruyama N, Ishibashi T, Reeves KR (2007) Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose- response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther 29:1040\u20131056 ([PMID: 17692720])","journal-title":"Clin Ther"},{"key":"2684_CR28","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1080\/1462220031000070552","volume":"5","author":"JR Hughes","year":"2003","unstructured":"Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE (2003) Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res 5:13\u201325 ([PMID: 12745503])","journal-title":"Nicotine Tob Res"},{"key":"2684_CR29","doi-asserted-by":"publisher","first-page":"1206","DOI":"10.1161\/01.HYP.0000107251.49515.c2","volume":"42","author":"AV Chobanian","year":"2003","unstructured":"Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr et al (2003) Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension 42:1206\u20131252. https:\/\/doi.org\/10.1161\/01.HYP.0000107251.49515.c2","journal-title":"Hypertension"},{"issue":"1","key":"2684_CR30","doi-asserted-by":"publisher","first-page":"75","DOI":"10.1093\/ntr\/ntr137","volume":"14","author":"K Fagerstr\u00f6m","year":"2012","unstructured":"Fagerstr\u00f6m K (2012) Determinants of tobacco use and renaming the FTND to the Fagerstr\u00f6m Test for Cigarette Dependence. Nicotine Tob Res 14(1):75\u201378","journal-title":"Nicotine Tob Res"},{"key":"2684_CR31","volume-title":"Beck depression inventory II","author":"AT Beck","year":"2006","unstructured":"Beck AT, Steer RA, Brown G (2006) Beck depression inventory II. Giunti O.S, Florence"},{"key":"2684_CR32","volume-title":"Beck anxiety inventory","author":"AT Beck","year":"2006","unstructured":"Beck AT, Steer RA (2006) Beck anxiety inventory. Giunti O.S, Florence"},{"issue":"2","key":"2684_CR33","doi-asserted-by":"publisher","first-page":"256","DOI":"10.1016\/j.rmed.2007.09.004","volume":"102","author":"G Piccillo","year":"2008","unstructured":"Piccillo G, Caponnetto P, Barton S, Russo C, Origlio A, Bonaccorsi A, Di Maria A, Oliveri C, Polosa R (2008) Changes in airway hyperresponsiveness following smoking cessation: comparisons between Mch and AMP. Respir Med 102(2):256\u2013265","journal-title":"Respir Med"},{"issue":"6","key":"2684_CR34","doi-asserted-by":"publisher","first-page":"616","DOI":"10.1111\/j.1365-2362.2010.02449.x","volume":"41","author":"P Caponnetto","year":"2011","unstructured":"Caponnetto P, Russo C, Di Maria A, Morjaria JB, Barton S, Guarino F, Basile E, Proiti M, Bertino G, Cacciola RR, Polosa R (2011) Circulating endothelial-coagulative activation markers after smoking cessation: a 12-month observational study. Eur J Clin Invest 41(6):616\u2013626. https:\/\/doi.org\/10.1111\/j.1365-2362.2010.02449.x","journal-title":"Eur J Clin Invest"},{"key":"2684_CR35","doi-asserted-by":"publisher","first-page":"93","DOI":"10.1111\/jdi.12543","volume":"8","author":"S Tonstad","year":"2017","unstructured":"Tonstad S, Lawrence D (2017) Varenicline in smokers with diabetes: a pooled analysis of 15 randomized, placebo-controlled studies of varenicline. J Diabetes Investig 8:93\u2013100","journal-title":"J Diabetes Investig"},{"issue":"6","key":"2684_CR36","doi-asserted-by":"publisher","first-page":"491","DOI":"10.1007\/s11892-014-0491-3","volume":"14","author":"RI Holt","year":"2014","unstructured":"Holt RI, de Groot M, Golden SH (2014) Diabetes and depression. Curr Diab Rep 14(6):491. https:\/\/doi.org\/10.1007\/s11892-014-0491-3","journal-title":"Curr Diab Rep"}],"container-title":["Internal and Emergency Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11739-021-02684-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11739-021-02684-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11739-021-02684-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,10,10]],"date-time":"2021-10-10T16:39:23Z","timestamp":1633883963000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11739-021-02684-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,18]]},"references-count":36,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2021,10]]}},"alternative-id":["2684"],"URL":"https:\/\/doi.org\/10.1007\/s11739-021-02684-1","relation":{},"ISSN":["1828-0447","1970-9366"],"issn-type":[{"value":"1828-0447","type":"print"},{"value":"1970-9366","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3,18]]},"assertion":[{"value":"30 January 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"22 February 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 March 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"RP is full-time employee of the University of Catania, Italy and Medical Director of the Institute for Internal Medicine and Clinical Immunology at the same University. In relation to his work in the area of tobacco control and respiratory diseases, RP has received has received lecture fees and research funding from Pfizer, GlaxoSmithKline, CV Therapeutics, NeuroSearch A\/S, Sandoz, MSD, Boehringer Ingelheim, Novartis, Duska Therapeutics, and Forest Laboratories. He has also served as a consultant for Pfizer, Global Health Alliance for treatment of tobacco dependence, CV Therapeutics, Boehringer Ingelheim, Novartis, Duska Therapeutics, ECITA (Electronic Cigarette Industry Trade Association, in the UK), Arbi Group Srl., and Health Diplomats. RP has served on the Medical and Scientific Advisory Board (MSAB) of Cordex Pharma, Inc., CV Therapeutics, Duska Therapeutics Inc, Pfizer, and PharmaCielo. Lecture fees from a number of European EC industry and trade associations (including FIVAPE in France and FIESEL in Italy) were directly donated to vaper advocacy no-profit organizations. RP is also founder of: 1) the Center for Tobacco prevention and treatment (CPCT) at the University of Catania; and 2) the Center of Excellence for the acceleration of Harm Reduction (CoEHAR) at the same University, which has received support from Foundation for a Smoke Free World to conduct 8 independent investigator-initiated research projects on harm reduction. RP is also currently involved in the following pro bono activities: scientific advisor for LIAF, Lega Italiana Anti Fumo (Italian acronym for Italian Anti-Smoking League), the Consumer Advocates for Smoke-free Alternatives (CASAA) and the International Network of Nicotine Consumers Organizations (INNCO); Chair of the European Technical Committee for standardization on \u201cRequirements and test methods for emissions of electronic cigarettes\u201d (CEN\/TC 437; WG4). PC is paid by the University of Catania as an external part time researcher and adjunct professor of clinical, addiction and general psychology. He has been affiliated to the CoEHAR since December 2019 in a pro bono role. He is co-author of a protocol paper supported by an Investigator-Initiated Study award program established by Philip Morris International in 2017. All other authors have no relevant conflict of interest to declare in relation to this study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This article does not contain any studies with human or animal subjects performed by the any of the authors.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Human and animal rights statement"}},{"value":"For this type of study, formal consent is not required.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}